A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers

Pfizer48 enrolled

Overview

The purpose this study is to evaluate the safety and toleration of PF-03049423 following multiple dose administration as an oral solution to healthy young adult volunteers and healthy elderly volunteers. The study will also evaluate the pharmacokinetics of PF-03049423 after multiple dose administration to healthy young adult volunteers and healthy elderly volunteers. The study will also explore the relationship between blood pressure (supine and standing) and PF-03049423 concentration.

The purpose of the investigation is to evaluate the safety and tolerability of an investigational new drug, PF-03049423, when dosed for two weeks in both healthy younger and healthy older subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-03049423DRUG

PF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers

PF-03049423DRUG

PF-03049423 in oral solution, 7.5 mg, given once daily for 14 days; healthy young adult volunteers

PF-03049423DRUG

PF-03049423 in oral solution, 6 mg, given once daily for 7 days, then 12 mg given once daily for 7 days; healthy young adult volunteers

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy persons, male or female. * For the healthy young adult cohort, subjects must be 18 to 50 years old, inclusive. * For the healthy elderly adult cohort, subjects must be 51 to 99 years old, inclusive. * Body Mass Index (BMI) of 18 to 35; and a total body weight \>50 kg (110 lbs) Exclusion Criteria: * Subjects with clinically significant medical conditions. * Women of non-child bearing potential. * Subjects with a known medical history of hearing loss/disability or nonarteritic ischemic optic neuropathy. * A positive urine drug screen.

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Safety laboratory assessments, vital signs (including supine and standing blood pressure), physical examination, 12-lead ECGs and adverse events.

Time frame: Days 1 through 14

PK Parameters:Day 1: Area under concentration time curve from hour 0 to the last dosing interval (AUCtau), maximum observed concentration (Cmax), and time of maximum observed concentration (Tmax), for PF-03049423 in plasma.

Time frame: Day 1

PK Parameters: Day 14: Cmax at steady state, Tmax, AUCtau at steady state , t½, Cavg at steady state, Cmin at steady state, Cmax at steady state /Cmax sd, AUCtau at steady state/ AUCtau sd, Ae% and CLr.

Time frame: Day 14

Secondary Outcomes

Blood pressure

Time frame: Days 1 to 14

Data from ClinicalTrials.gov

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